Unione europea — decisioni della Commissione europea
Revoche e sospensioni, ritiri di lotti, farmaci carenti, note di sicurezza, rimborsabilità e nuovi medicinali — ogni giorno, automaticamente. Ultimo aggiornamento: 10/11/2026 08:15.
n. EU/1/06/336 · autorizzato il 24/04/2006 · Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following … · Pfizer Europe MA EEIG · Tigecycline · ATC J01AA12
n. EU/1/08/442 · autorizzato il 18/03/2008 · Primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total h… · Boehringer Ingelheim International GmbH · dabigatran etexilate mesilate · ATC B01AE07
n. EU/1/07/418 · autorizzato il 18/09/2007 · CELSENTRI, in combination with other antiretroviral medicinal products, is indicated for treatment-experienced… · ViiV Healthcare BV · maraviroc · ATC J05AX09
n. EU/1/09/600 · autorizzato il 30/11/2009 · Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one w… · Biotest Pharma GmbH · Human Hepatitis B Immunoglobulin · ATC J06BB04
n. EU/1/25/1974 · autorizzato il 22/12/2025 · WAYRILZ is indicated for the treatment of immune thrombocytopenia (ITP) in adult patients who are refractory t… · Sanofi B.V. · rilzabrutinib · ATC Pending
n. EU/1/22/1645 · autorizzato il 25/04/2022 · Vydura is indicated for the
• Acute treatment of migraine with or without aura in adults;
• Preventive trea… · Pfizer Europe MA EEIG · rimegepant · ATC N02CD
n. EU/1/20/1481 · autorizzato il 17/12/2020 · Vocabria injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunod… · ViiV Healthcare BV · cabotegravir · ATC J05AJ04
n. EU/1/20/1452 · autorizzato il 25/06/2020 · Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and in… · Bristol-Myers Squibb Pharma EEIG · luspatercept · ATC B03XA06
n. EU/1/17/1191 · autorizzato il 08/05/2017 · Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who ha… · Recordati Netherlands B.V. · dinutuximab beta · ATC L01FX06
n. EU/1/15/1024 · autorizzato il 17/07/2015 · Melanoma
KEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and o… · Merck Sharp & Dohme B.V. · pembrolizumab · ATC L01FF02
n. EU/1/18/1337 · autorizzato il 11/01/2019 · This medicinal product is for diagnostic use only.
GHRYVELIN is indicated for the diagnosis of growth hormone… · Atnahs Pharma Netherlands B.V. · macimorelin · ATC V04CD06
n. EU/1/20/1508 · autorizzato il 18/01/2021 · <u>Breast cancer</u>
<i>HER2-positive breast cancer</i>
Enhertu in combination with pertuzumab is indicate… · Daiichi Sankyo Europe GmbH · trastuzumab deruxtecan · ATC L01FD04
n. EU/1/97/053 · autorizzato il 17/11/1997 · Cerezyme (imiglucerase) is indicated for use as long-term enzyme replacement therapy in patients with a confir… · Sanofi B.V. · imiglucerase · ATC A16AB02
n. EU/1/24/1851 · autorizzato il 19/09/2024 · Anzupgo is indicated for the treatment of moderate to severe chronic hand eczema (CHE) in adults and adolescen… · LEO Pharma A/S · delgocitinib · ATC D11AH11
n. EU/1/21/1615 · autorizzato il 13/04/2022 · <u>Muscle invasive bladder cancer (MIBC)</u>
Padcev, in combination with pembrolizumab, as neoadjuvant trea… · Astellas Pharma Europe B.V. · enfortumab vedotin · ATC L01FX13
n. EU/1/17/1231 · autorizzato il 08/01/2018 · Ocrevus is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with … · Roche Registration GmbH · ocrelizumab · ATC L04AG08
n. EU/1/11/676 · autorizzato il 17/03/2011 · JEVTANA in combination with prednisone or prednisolone is indicated for the treatment of adult patients with m… · Sanofi Winthrop Industrie · cabazitaxel · ATC L01CD04
n. EU/1/24/1872 · autorizzato il 12/12/2024 · Adult Crohn’s disease
IMULDOSA is indicated for the treatment of adult patients with moderately to severely … · Accord Healthcare S.L.U. · ustekinumab · ATC L04AC05
n. EU/1/23/1760 · autorizzato il 15/09/2023 · Apretude is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce th… · ViiV Healthcare BV · cabotegravir · ATC J05AJ04
n. EU/1/25/1961 · autorizzato il 14/08/2025 · Vgenfli is indicated for adults for the treatment of
• neovascular (wet) age-related macular degeneration (AM… · Zakłady Farmaceutyczne POLPHARMA S.A. · aflibercept · ATC S01LA05
n. EU/1/17/1251 · autorizzato il 08/02/2018 · Ozempic is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an… · Novo Nordisk A/S · semaglutide · ATC A10BJ06
n. EU/1/24/1859 · autorizzato il 27/09/2024 · Yuvanci is indicated as substitution therapy for the long-term treatment of pulmonary arterial hypertension (P… · Janssen-Cilag International NV · Macitentan / Tadalafil · ATC C02KX54
n. EU/1/13/904 · autorizzato il 21/02/2014 · Mirvaso is indicated for the symptomatic treatment of facial erythema of rosacea in adult patients. · Galderma S.A.,the Netherlands Branch · brimonidine · ATC D11AX21
n. EU/1/13/880 · autorizzato il 04/12/2013 · Treatment of patients with moderate to severe Alzheimer's disease. · Accord Healthcare S.L.U. · memantine · ATC N06DX01
n. EU/1/15/1076 · autorizzato il 18/02/2016 · Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Kova… · Bayer AG · octocog alfa · ATC B02BD02
n. EU/1/24/1873 · autorizzato il 12/02/2025 · Kostaive is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years… · Arcturus Therapeutics Europe B.V. · zapomeran · ATC J07BX03
n. EU/1/24/1866 · autorizzato il 14/11/2024 · ELAHERE as monotherapy is indicated for the treatment of adult patients with folate receptor-alpha (FRα) posit… · AbbVie Deutschland GmbH & Co. KG · mirvetuximab soravtansine · ATC L01FX26
n. EU/1/26/2029 · autorizzato il 27/04/2026 · Dazparda is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and a… · Sandoz GmbH · insulin aspart · ATC A10AB05
n. EU/1/10/636 · autorizzato il 05/07/2010 · Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post… · AstraZeneca AB · roflumilast · ATC R03DX07
n. EU/1/21/1579 · autorizzato il 24/06/2022 · Nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of p… · Sanofi B.V. · avalglucosidase alfa · ATC A16AB22
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